Adaptive Trial Design
pharmafile | November 24, 2011 | Feature | Research and Development |
Despite the burgeoning interest in Adaptive Trial Design (ATD), an extremely powerful tool when used effectively in the appropriate circumstances, it is neither new nor a universal panacea for all the ills of Clinical Development. Used without thought however, it is potentially counter-productive and very expensive in terms of time, resource and money.
Regardless of its increasing profile, the innovation behind this apparently new initiative actually started over 10 years ago, when Pfizer, Duke University and Tessella combined their collective knowledge and designed the ASTIN trial. They used the first truly adaptive design protocol in a pivotal trial to define dose-response, identify the optimum dose and establish clinical benefit. Ultimately the trial was stopped early for futility, resulting in fewer patients being unnecessarily exposed to treatment and less expense being incurred by Pfizer. The drug may not have succeeded but the trial did, and with it started a slow burning revolution